Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-HD-09-027

Related Notices

  • July 11, 2013 - This RFA has been reissued as RFA-AR-13-021.
  • June 7, 2013 - See Notice NOT-AR-13-020. Notice of Intent to Publish a Funding Opportunity Announcement (FOA) for the Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers (U54).

Funding Opportunity Announcement (FOA) Number

RFA-AR-13-012

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865, 93.846, 93.837, 93.853

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to publicize the re-competition of Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers (MDCRCs). These Centers promote collaborative basic, translational and clinical research and provide important resources that can be used by the national muscular dystrophy research communities. The centers also provide an outstanding environment for the training and career development of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Finally, center investigators are expected to participate in important community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public.

Key Dates
Posted Date

July 27, 2012

Letter of Intent Due Date

October 19, 2012

Application Due Date(s)

November 19, 2012

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March, 2013

Advisory Council Review

May, 2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

November 20, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit competitive applications for Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers (MDCRCs). These Centers promote collaborative basic, translational and clinical research and provide important resources that can be used by the national muscular dystrophy research communities. The Centers also provide an outstanding environment for the training and career development of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Finally, Center investigators are expected to participate in important community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public. 

Background

The Muscular Dystrophy Community Assistance, Research, and Education Amendments of 2001 (the MD-CARE Act, Public Law 107-84) specified a number of provisions for expanding and intensifying research on muscular dystrophy. One provision of the MD-CARE Act was that the NIH establish centers of excellence for research on muscular dystrophy. The MDCRCs program was subsequently developed in honor of Senator Paul D. Wellstone, a champion of muscular dystrophy research. In the years following the MD-CARE Act, the NIH sponsored Requests for Applications in 2003, 2004, 2008 and 2009 and has supported six active MDCRCs.

Reauthorization of the MD-CARE Act in 2008 codified the MDCRCs as the Paul D. Wellstone MDCRCs. MDCRCs funded through this program have contributed toward the goal of improving the detection, diagnosis, and treatment of the muscular dystrophies.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Heart, Lung, and Blood Institute (NHLBI) are committed to continuing and enhancing the tradition of scientific excellence that has been fostered in the MDCRC program.

Muscular dystrophy refers to a group of hereditary, progressive degenerative disorders causing weakness of the skeletal or voluntary muscles. There are many different forms of muscular dystrophy, which differ in their age of onset, penetrance, severity, and pattern of muscles affected. Most types of muscular dystrophy are not simply muscle disorders, but rather multi-system disorders with manifestations in a variety of body systems, including the heart, gastrointestinal system, endocrine glands, skin, eyes, brain, and other organ systems. The major forms of muscular dystrophy include congenital, distal, Duchenne/Becker, Emery-Dreifuss, facioscapulohumeral, limb-girdle, myotonic, and oculopharyngeal. Although some forms first become apparent in early childhood, others may not appear until middle age or later, but all have a significant clinical, economic, and psychosocial burden of disease.

While several therapeutic development strategies have shown promise in cell-based or animal models, and some early stage clinical trials in humans have begun, currently available therapies are very limited in their ability to change the clinical course of the diseases. Moreover, there is currently no consensus as to which of several potential therapeutic strategies, or combination of strategies, may ultimately prove successful in reducing patient morbidity and mortality. Symptomatic treatment, though not able to stop disease progression, may improve the quality of life for some individuals. Recent advances in genetics, pathogenic mechanisms, therapeutic technology, and patient diagnostics do provide compelling opportunities for advancing translational and clinical science in the muscular dystrophies. In addition to the need for new disease or symptom modifying therapies, there are gaps in understanding how the muscular dystrophies affect the lives of patients and their families.  Filling these gaps in understanding may lead to novel strategies to lessen the burden of these diseases.  For examples, better understanding of patient secondary conditions and neuropsychological and neurobehavioral profiles that affect quality of life and caregiver burden could lead to effective interventions.

The Action Plan for the Muscular Dystrophies (http://www.ninds.nih.gov/find_people/groups/mdcc/MDCC_Action_Plan.doc), approved and released in January 2006 by the interagency Muscular Dystrophy Coordinating Committee (http://www.ninds.nih.gov/find_people/groups/mdcc/index.htm), is a consensus document with input from patients, advocacy groups, basic scientists, clinicians, and Federal agencies that highlights many of these scientific opportunities and the need for broad cooperation in seeking effective treatments for the muscular dystrophies.

Specific Objectives of the Research Program

NIAMS, NICHD, NINDS, and NHLBI seek to further develop the MDCRC program to further foster the translation of scientific findings and technological developments into the clinical research setting, and also to bring observations and findings from the clinical setting into the laboratory for more in depth analysis and hypothesis testing. This FOA solicits both new (type 1) and competitive renewal (type 2) applications for MDCRCs. Under the FOA, each Center may contain a mixture of basic, translational, or clinical research, as long as efforts are directed toward the steps required for the development of therapies, which include drugs, biologics, exercise, behavioral and other interventions. The steps required for development of therapies may include, but are not limited to:

MDCRC applicants are encouraged to consider projects that address the high priority areas described in the Action Plan for the Muscular Dystrophies (http://www.ninds.nih.gov/find_people/groups/mdcc/MDCC_Action_Plan.doc). This includes clinical research on MD-associated cardiomyopathy.

Applicants seeking support for projects that are stand-alone, single-component basic, translational, clinical studies or trials in muscular dystrophy should contact the Program Officers listed in Section VII. “Agency Contacts” below for guidance on other, more appropriate funding opportunities. 

Collectively and in cooperation with the NIH, the MDCRCs form part of a coordinated national program. Applicants are expected to emphasize new ideas, novel approaches, and state-of-the-art technologies to address the needs for effective treatments and other strategies to improve the lives of muscular dystrophy patients.  Multidisciplinary collaborative efforts, in particular those involving basic scientists and clinicians with appropriate expertise, are required in each MDCRC. MDCRC applicants must also propose resource core facilities and training activities that will enhance muscular dystrophy research on a national or international level.

General Description of MDCRC and Center Components

The organizational structure of the proposed MDCRC should facilitate the flow of new scientific findings and technologies into translational and clinical research. Each center may contain any combination of basic, translational, or clinical studies research with an emphasis placed upon moving the research field forward toward novel or improved therapies for any of the muscular dystrophies. Each center must include clinical research as defined in the PHS398 Supplemental Instructions Part II (http://grants1.nih.gov/grants/funding/phs398/phs398.html). This includes patient-oriented research, for which an investigator directly interacts with human subjects, epidemiologic, behavioral studies, outcomes and health services research. Studies are not considered clinical research if they involve only human specimens without information identifying the subjects. Although guidance is provided in this FOA for interventional clinical trials in MDCRCs, clinical trials using investigational drugs or biologics are NOT a required component of an MDCRC.

The minimal structural requirements of a Wellstone MDCRC under this FOA are:

Projects

Each of the proposed research projects should address problems that require a substantial collaborative research effort to solve, and are best suited for a Center environment rather than a stand-alone grant.  Collectively, the projects should involve synergistic teams of researchers with complementary expertise such as basic and clinical, skeletal muscle and other organ systems, primary data collection and bioinformatics, etc. Collaborations should be arranged to bring the best expertise to bear on a problem, whether the proposed collaborations are all on-site or utilize consortium agreements with off-site investigators at existing MDCRCs or off-site investigators not affiliated with an MDCRC.

For Centers that propose an interventional clinical trial, there should be strong evidence provided in support of the potential value and feasibility of successfully completing the study within the term of the grant, including clear preclinical rationale, evidence that regulatory requirements will be met in a timely manner, evidence of drug/biologic availability for use in a trial, and agreement of all participating clinical/corporate partners.  Preclinical rationale should be provided in the application, ensuring that the rigor of preclinical efficacy studies and the level of effect of the agent are both sufficient to warrant clinical testing of the agent (see http://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-023.html).  Clinical trials involving the testing of new investigational therapeutics, new indications for FDA-approved drugs, or other medical interventions under a research protocol should be performed under an IND, unless otherwise agreed upon by the FDA.  If not exempt, the applicant must provide the NIH with the name and organization of the IND/IDE holder, the date the IND/IDE was filed with the FDA, the FDA IND/IDE number, and any comments from the FDA regarding this protocol.  Studies will not be funded unless necessary regulatory approval has first been obtained; regulatory approval at the time of application is preferred.  In studies where a pharmaceutical/biotechnology company is providing the study agent, a written agreement by a company official affirming this arrangement must be provided with the application.  It is strongly encouraged that clinical studies utilize established Common Data Elements (CDEs; see http://www.commondataelements.ninds.nih.gov/#page=Default) to ensure comparability with other clinical trials in muscular dystrophy.

Leadership

The Center Director and Co-Director should each have a minimum commitment of 20% (2.4 calendar months) effort to the MDCRC.  They should develop and maintain a center environment that fosters traditional and novel approaches to multi-disciplinary research collaborations and training. The Center Director and Co-Director cannot serve as project Principal Investigators on another active MDCRC award.

Administrative Core

The Administrative Core should provide for the integration and management of activities within the MDCRC. Applicants should specify appropriate administrative/business management staff and oversight mechanisms by the Center Director, Center Co-Director, and a local Executive Committee. Each Center should expect to form an external Center Advisory Committee (CAC) with scientific, clinical and patient advocate representation, composed of at least five members.  The composition of the CAC will require NIH approval.   The CAC should meet in-person or electronically approximately once a year, beginning in the first or second year of the Center award.   Funded MDCRCs are expected to utilize the Administrative Core to establish and maintain a website to communicate the Center missions and the availability of training opportunities and Scientific Research Resource Core services. Applicants are encouraged to form the strongest teams to address the research questions, regardless of geography.  When multiple performance sites are planned, the Administrative Core should include leadership and communication plans adequate to manage the multiple sites.

Shared Resource Core

The shared Scientific Research Resource Core should be designed and managed to support the research of the MDCRC, as well as serving as a resource for the national and perhaps international muscular dystrophy research community.   Applicants may wish to consult the Action Plan for the Muscular Dystrophies (http://www.ninds.nih.gov/find_people/groups/mdcc/MDCC_Action_Plan.doc) for consensus statements on infrastructure needs of the muscular dystrophy research community.

Training and Education Core

As nationally recognized centers of excellence in muscular dystrophy, the MDCRCs are expected to play leadership roles in training of new researchers for the muscular dystrophy field and educating the patient and lay communities regarding research activities. Each center should include plans for a Research Training and Education Core to establish and maintain a training environment for predoctoral and postdoctoral investigators in muscular dystrophy research, and to engage the patient and lay community in educational and research activities. Utilization and adaptation of existing training programs is encouraged. The training environment for the center may include formal training on manuscript writing and reviewing, grantsmanship, team science approaches and lab management and must include training on the ethical conduct of research. Other features of the training environment may include a seminar program, retreats for presentation of trainee research, journal clubs or other activities that contribute to the preparation of junior investigators for careers in muscular dystrophy research. Lab rotations for predoctoral students should involve exposure to translational and clinical research whenever possible and may include rotations at other Wellstone Centers. In order to promote awareness of muscular dystrophy research and the Wellstone Centers program in the patient and lay communities, this core should develop educational activities or materials such as seminars, web-based information, or lab tours involving patients and their families interacting with junior and senior investigators. Participation of patient advocacy groups in the planning and conduct of education and outreach activities is encouraged.

This core should also request funds to support one predoctoral and one postdoctoral training slot in addition to the positions associated with each project. Centers are encouraged to recruit clinical fellows or predoctoral trainees interested in careers as clinical researchers.  Short-term training opportunities for medical students are also encouraged as part of this core.   Funds for training slots may include salary, fringe benefits, tuition, travel and trainee related expenses. Each trainee must be engaged in full-time research and training activities and may occupy one of these slots for no more than 2 years in total. Trainees appointed to these slots do not require United States citizenship or permanent residence status. Selection of candidates for these slots should be determined by the center’s CAC and based on a process and selection criteria to be described in the application. Appointment of the candidates will require NIH approval and documentation of the merits of the candidate and proposed research and the recommendation of the CAC. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

The Wellstone Network

Recipients of MDCRC awards will become part of a national program in muscular dystrophy and will be expected to participate in MDCRC activities, including meetings of the Steering Committee (composed of MDCRC Directors and Co-Directors, and NIH staff) and an annual MDCRC meeting that rotates among the MDCRC sites.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2013:

NIAMS, up to $1,500,000 total cost, 1 award, NINDS, up to $1,500,000 total cost, 1 award, NICHD, up to $1,500,000 total cost, 1 award, NHLBI, up to $250,000 total costs, 1 award.

Award Budget

Applicants may request up to $1M in direct costs/year (exclusive of facilities and administrative costs of subcontracts with collaborating organizations.

Award Project Period

The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Glen H. Nuckolls, Ph.D.
Director, Muscle Disorders and Therapies Program
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892-4872
Telephone: 301-594-4974
Email: nuckollg@mail.nih.gov  

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

W. Ernest Lyons, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: 301-496-9223
FAX: 301-402-0182
Email: nindsreview.nih.gov@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Each MDCRC must include at least two highly meritorious scientific projects, with at least one involving clinical research.  Each MDCRC must also have an Administrative Core to coordinate efforts within the Center and promote collaborations with investigators outside the Center, at least one Scientific Research Resource Core providing services and/or resources to researchers within and outside the Center, and a Training and Education Core to enhance the training environment, provide stipend support and engage the patient and/or lay community in education, research or other outreach activities. The Program Director/Principal Investigator must lead one of the projects.

Program Introduction, Statement of Objectives, Qualifications of the Leadership, and Organizational Structure (12 pages):

Include a section in the application describing the overall Center.  Describe the major theme of the Center, its goals and objectives, background information and the overall importance of the research to the development of therapies for the muscular dystrophies. Describe the rationale for the total proposed program. Explain the strategy for achieving the goals defined for the overall program and how each research project and core relates to that strategy.  A successful Center grant application will include a well-integrated research plan that clearly shows how the proposed projects and cores will foster preclinical and or clinical development of novel therapeutics for muscular dystrophy. The program should be viewed as interrelated research projects, each of which is not only individually scientifically meritorious but is also complementary to the other projects, and related to the overall theme developed for the Center.  Provide justification in the application that: (a) the proposed projects are such that they require an intensive collaborative effort to succeed and (b) that key personnel will collaborate effectively.

Each applicant institution will name an MDCRC Center Director (Program Director/Principal Investigator) who will be the key figure in the administration, management, and coordination of the Center grant. The Director will be responsible for the organization and operation of the center. The Director should be a recognized scientific leader experienced in the field of muscular dystrophy research and must be able to coordinate, integrate, and provide guidance in the establishment of research programs. A Co-Director should also be named who will be involved in the administrative and scientific efforts of the Center. Describe the roles of the Director and Co-Director and their qualifications as leaders of the Center. 

Describe the organizational structure of the MDCRC including the components of the Center and any existing resources of the institution(s) that will be leveraged by the Center.  Also describe any connections between the proposed Center and other organizations such as patient advocacy groups or industry partners.  Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how combined resources create capabilities that are more than the sum of the parts. 

Administrative Core (12 pages):

The Administrative Core will be responsible for the management and administration of the overall Center.  This section of the application should describe the strategies and processes that will be used to manage the Center and achieve the goals.  This Core, led by the Center Director, will provide oversight for the projects and cores, promote coordination and collaboration within the Center and with investigators and organizations outside the Center.  A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; and the maintenance of ongoing communication.  Indicate who will be responsible for each of these activities.

The Administrative Core should provide oversight of the resource sharing plans of the Center.  Applicants should provide a plan regarding the timely sharing of specimens, cells, animal models and redacted data generated with support from this award with other qualified research scientists, both within and outside the MDCRC network, and ensuring that such data are HIPPA compliant.  Describe plans for tracking requests for resources and monitoring the timely accomplishment of the activities described in the resource sharing plans. 

The Administrative Core should establish an Executive Committee, composed of members of the Center and a Center Advisory Committee, composed of people outside the Center.  Describe how the Center Advisory Committee will contribute to oversight of the research projects, core facilities and training environment of the Center.  The Center Advisory Committee should meet approximately once a year and brief reports of the proceedings of the meeting and recommendations of the committee should be included in the progress reports of the Center.  Describe plans as to how you will work with the Center Advisory Committee, but do not name the members in the application.

In order to assure active collaboration with other Centers, the MDCRC Director, Co-Director, and other staff should attend annual meetings of the MDCRC Network, contribute to the coordination of effort, and/or help to refine and standardize operating procedures among the Centers. The Administrative Core of the MDCRC application should include up to $5,000 per year direct costs for travel of the Director, Co-Director, and other Center investigators to the annual meeting of the Wellstone Network, and for visits of Center investigators or trainees to other MDCRCs or other collaborative sites to exchange scientific ideas, to plan multi-Center research projects, or to receive training in specialized techniques.

Individual Research Projects:

Follow the instructions for the PHS 398 Components as described in the PHS SF424 R&R Guide for each project and core.  The page limits for each project and core are: one page for the specific aims, 12 pages for the research strategy (significance, innovation, approach), including all tables, graphs, figures, diagrams and charts.  Preliminary studies for new applications and the progress report for renewal applications should be included within this page limit. 

Each project should clearly state its overall objective and explain its relevance to the central theme of the Center. In addition, an explanation should be included describing how the project relates to and both complements and enhances the other research projects and cores of the program. Why the project is best suited to be carried out in the Center environment should be highlighted. Specify the overall biomedical significance of the work proposed. Specify the niches filled by each project in advancing treatments for muscular dystrophy.

Subjects who participate in MDCRC clinical research projects should be fully informed, using appropriate consent procedures. The consent form for funded projects should specifically address the following: (1) disclosure that biological materials and clinical data will be distributed to other researchers; (2) assurance that such data will be de-identified and stored and maintained without personal identifiers; (3) disclosure that analyses of these data will be conducted by other scientists currently not included within the current research team, potentially including those with commercial interests; (4) that the data collected by the researchers may be used to study their specific disorder as well as other disorders.

Each MDCRC should contain at least one clinical study, but this study is not required to be an interventional clinical trial.  Options for clinical studies include but are not restricted to evaluation of natural history, development of biomarkers, or development/validation of endpoint measures.  Knowledge from such clinical studies is essential to direct subsequent clinical trials and can be invaluable for the muscular dystrophy field. 

Because of the budget limitation of the overall Center and requirements for other components, any interventional clinical trials proposed as part of the MDCRCs are likely to be phase 0/exploratory IND, phase 1, or early stage proof of concept trials.  Any clinical trial proposed within MDCRCs should be designed to validate the therapeutic target or candidate therapeutic (phase 0 trial) or to provide specific data that will be necessary to design a subsequent definitive efficacy trial (phase 1 or early stage proof of concept trial). The proposed study must address questions that, when answered, will optimize the design of the eventual definitive clinical trial rather than simply address the clinical question with lower power.  Underpowered efficacy trials that are unlikely to advance the development of a candidate therapeutic should be avoided.  Examples of relevant clinical research include, but are not limited to, the following:

Scientific Core(s): 

Describe the function of the core as a resource to the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide.  A core is principally designed as a service or resource component; it would be highly unusual to include research in a core (a possible exception would be methodology development). Please contact the Institute staff if you require guidance on this issue.

Describe the role of the core as a resource to the program as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program.  To aid in the review of your application it is recommended that you prepare in tabular form information concerning the research projects that each facility core unit would serve and the proportion of the cost of the facility core unit associated with each research project involved.

Cores are seldom created specifically for the MDCRC and more often already exist in some form prior to the application.  When proposing support for an already existing core, describe how the MDCRC award would enhance the resources or services already available through new innovation and technology development, expanded availability, increased throughput, etc. 

Each Center should contain a scientific core that provides services and/or resources that are shared with other investigators nationally and perhaps internationally.  These resources could be reagents, specimens, services or technical expertise that will help to accelerate progress of multiple projects toward the development of therapies or other strategies for improving the lives of patients with muscular dystrophy.  Describe how this shared core will meet the needs of the national/international muscular dystrophy research community.  If cores providing similar resources are already available, explain the need for this additional core.

Additional cores may be proposed if they are needed to advance the local research effort and if they fit within the budget limits described elsewhere in this FOA.  For each scientific core, the applicant should identify projects that will depend on the services and/or resources proposed.  Projects outside the Center that would use the core should be described in general terms and investigators outside the Center should not be named, as this would lead to conflicts of interest during peer review. 

Training and Education Core:

The Training and Education Core budget should include 10 percent of the total Center budget (up to $100,000/year) for the purpose of enhancing the environment within the Center for recruiting and training the next generation muscular dystrophy researchers. Included in this core budget should be support for one predoctoral and one postdoctoral fellow as well as support for activities that educate and/or engage patients and patient advocates in the research conducted by the center. Centers are encouraged to recruit clinical fellows or predoctoral trainees interested in careers as clinical researchers.  Short-term training opportunities for medical students are also encouraged as part of this core.  Describe the processes that will be used by the Center to publicize these training opportunities, solicit applications from candidates, involve the Center Advisory Committee in evaluation of the candidates, select the trainees and monitor their research and career development progress.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Centers should be designed to include the following components: two or more scientific project(s), an Administrative Core, a Shared Scientific Research Resource Core with national impact, and a Research Training and Education Core. Applications may include additional core facilities within the overall budget cap. After the review of the individual components, an overall impact/priority score will be assigned to the center application. The overall score will reflect a) the scientific merits of the research project(s), b) the overall effectiveness and adequacy of core resources and facilities, c) the qualifications of the Center Director and Co-Director, d) the quality of the plans for management and oversight of the Center, e) the institutional commitment, and f) the synergy among the components and overall impact of the Center. The overall score for the center application may be higher or lower than the average of the individual components based on the assessment of whether the whole is greater than the sum of its parts.

For applications for renewal of previously funded Wellstone Centers, the productivity of the Center and its impact on the muscular dystrophy research field over the period of Center funding will also be taken into consideration when determining the overall score. Applicants should carefully document achievement of the goals of the prior funding period, including providing evidence of the value of their Scientific and Training and Education Cores.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Are the qualifications, experience, and commitment of the MDCRC Director adequate to lead the Center program and are they devoting sufficient time/effort to achieve Center goals? Does the Center Director have sufficient authority and credibility within the institution and broader community as a base for serving a national leadership role in muscular dystrophy? Does the Center Co-Director have appropriate complementary and integrated experience/expertise to help lead a multi-disciplinary center effort? Are there adequate plans for interaction among Center personnel and any off-site investigators? Is the Center scientific and administrative structure sufficient, including its internal and external procedures for monitoring and evaluating the proposed research? Are the proposed financial administration, procurement, property and personnel management, planning, and budget functions adequate? Are resource and informatics management plans adequate? Is the Center Advisory Committee activity plan appropriate to provide guidance for the central objectives of the Center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?       

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Administrative Core

Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.? Is there an appropriate plan for establishing and maintaining effective communications and cooperation among Center investigators and with investigators outside the Center? Is the Center scientific and administrative structure sufficient, including its internal and external procedures for monitoring and evaluating the proposed research projects and core facilities/resources? Are there appropriate plans for establishing the Center Advisory Committee and will this Committee contribute to the oversight of Center research projects, the Shared Resource Core, the Training and Education Core and other components? Are there appropriate plans for establishing and maintaining a website for the Center that provides useful information to the research community about shared resources and helps to inform the patient community about the research and other activities of the Center?

Center Synergy

Will the Center be effective in significantly accelerating progress toward effective treatments or other improvements in the lives of muscular dystrophy patients through coordinated and synergistic research and infrastructure activities? Are the aggregate quality and novelty of the Center’s research base sufficient and are the proposed research projects highly relevant to the overall goal of advancing therapeutic development in muscular dystrophy? Are there clear scientific merit and thematic identity to combining the component parts into an MDCRC? Are there appropriate plans for the Center to collaborate and otherwise contribute to the national MDCRC program, through participating in the annual meeting, workshops, training, collaborative efforts, or other MDCRC-wide activities?

Scientific Project(s)

For each scientific project, peer reviewers will evaluate the significance, approach, innovation, investigators and environment as described above.  The following additional criteria will also be considered in determining the score. Is the proposed project sufficiently novel and meritorious and the research plan feasible, in addressing one or more stages in the development of therapies or other strategies to improve the lives of muscular dystrophy patients? Are the experimental design and methods adequate to achieve the research objectives? For disease mechanism/therapeutic target identification and validation projects, is a plan provided as to how these efforts help to support the therapeutic development pipeline? For preclinical translational research projects, is there a clear step-by-step plan, including adequate milestones, to track and evaluate the therapeutic development effort? For clinical studies or trials, is there a clear need for the data or resource for future clinical trials or is there clear justification for moving the selected candidate therapeutic(s) forward with proof of concept or safety trials? Are there appropriate plans for the rigorous management and quality control of any research data or materials to be obtained from human subjects? For all types of research projects, do the problems to be addressed require both a center atmosphere and an intensive collaborative effort for successful completion? Do the participating investigators have sufficient experience and expertise for the proposed project and are time/effort commitments sufficient? Do the collaborative efforts require substantial, and not token, contributions from the partners for successful completion? Are the proposed protections for humans, animals, or the environment, to the extent they may be adversely affected by the projects proposed in the application, adequate?

Clinical Trials (if applicable)

Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Has the applicant addressed both the significance of the eventual definitive clinical trial AND the significance of this study in providing knowledge needed to proceed to the definitive clinical trial? Is there a sufficient body of high quality preclinical or clinical research that supports the rationale for the proposed study? What is the state of equipoise in the medical and patient communities with respect to the proposed intervention?  What is the potential for the proposed intervention to have a powerful influence on patient care and quality of life?  If the aims of the study are achieved, how will these results contribute to the design and implementation of the definitive clinical trial? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Have appropriate agreements with participating industry sponsors, if any, been established? Overall, is there compelling evidence in support of the therapeutic target and candidate therapeutic and is the trial feasible in terms of therapeutic agent availability, the participation of essential academic/corporate partners, and regulatory status that will not impede the timely initiation and completion of the study?

Scientific Research Resource Cores

Are the core activities capable of effectively and efficiently supporting research productivity and collaborations and are they essential to the mission of the Center? Is there adequate scientific and technical merit to justify the core? Does the core provide adequate leadership and technical expertise to ensure that it meets its stated goals? Are the staffing, allocated space and equipment, and budget that are available to the core sufficient to meet the anticipated demand on its services? Is there strong evidence via the core description that at least one Scientific Research Resource Core will serve as an important national/international resource for the muscular dystrophy research community? Is there sufficient likelihood that this shared core facility will be used by researchers within and outside the Center, and that the resources provided will significantly accelerate progress on the projects that make use of this core?  If other, similar cores are already available to the research community, is there still a significant need for this core? If the core facility is already established and supported by funding other than an MDCRC, how will the MDCRC award enhance the resources available?  If designed as a fee-for-service facility, are the projected fees appropriate for recovery of only the variable costs (supplies, service contracts, etc.) and do not assess the fixed costs of personnel and equipment? Is there a strong commitment to provide services to the national muscular dystrophy community and are plans for oversight and prioritization of user requests for core services adequate and fair?

Training and Education Core

How strong is the aggregate training record of the MDCRC investigators? Are there adequate plans to involve predoctoral students, postdoctoral research associates, and junior faculty in proposed and emergent research projects, especially those with clinical expertise or interest in careers in clinical muscular dystrophy research? Is an appropriate plan proposed for effective recruitment and selection of trainees and use of the designated Center training funds? Does the MDCRC have access to a sufficient pool of academically strong trainees and commensurate experience and well-qualified mentors to justify the proposed training activities and make effective use of the designated Center training funds? Are there adequate planning and infrastructure for trainee recruitment, selection, and retention? Are there appropriate plans for activities that will contribute to the education and/or direct involvement of patients and patient advocates in the research conducted by the Center?

Institutional Commitment

Is there tangible institutional commitment to the establishment and growth of the MDCRC? Will the institution provide incentives and rewards to promote the mission of team-based research? Is there substantial institutional commitment to tenured faculty positions, dedicated space and other resources, and sufficient time release to allow the investigators to pursue the goals of the MDCRC? Is the physical distribution of Center investigators and core resources conducive to the synergy necessary for a successful MDCRC? Will existing NIH-supported core facilities be shared with the MDCRC? Do the institutional administration and environment provide opportunities for Center growth? If applicable, are there sufficient commitment and support on the part of institutions associated with the MDCRC through consortium agreements?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.  

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. 

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Neurological Disorders and Stroke, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for: defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.  The Principal Investigator will serve as Center Director and together with a Center Co-Director, will be responsible for the integration and management of activities within the MDCRC.

The Center Director shall be responsible for organizing a local Executive Committee for day-to-day management of the MDCRC, and an external Center Advisory Committee, with scientific, clinical and patient advocate representation (final membership to be approved by the NIH). The role of these Committees will include the solicitation, review, and selection of proposals for trainee positions and collaborative projects, and the selection and prioritization of projects that will use resources and services that are provided for through the MDCRC. 

The Center Director and Co-Director of each MDCRC also serve as members of the MDCRC Steering Committee (see below) and are required to participate in its activities, to include regular conference calls and an annual MDCRC face-to-face meeting.

Awardees agree to participate in the overall coordination of NIH research efforts in muscular dystrophy. This participation may include collaboration and consultation with other NIH awardees, the sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection.

Awardees with a clinical trial component in their MDCRC agree to review of associated data, abstracts, and other publications by the DSMB and the NIH prior to their release.  

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Each MDCRC will have the support of Project Scientists, representing each participating Institutes, and a Program Official from NIH staff who are assigned administrative roles for the muscular dystrophies being studied and have expertise in the implementation of the MDCRC Program.

The NIH Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. The NIH Project Scientists also will assist in the interaction between the awardee and investigators of other institutions, as well as between the awardee and other Federal agencies and/or potential commercial sponsors. The NIH Project Scientists will be members of the MDCRC Steering Committee. The NIH Project Scientists retain the option to recommend additional research endeavors within the constraints of the approved research and negotiated budget. 

An important part of the NIH MDCRC Program is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different muscular dystrophies. The NIH Project Scientists will have the primary responsibility for this overall coordination.

The NIH may appoint an MDCRC External Advisory Committee (EAC), consisting of scientific and public members. The EAC may function in an advisory role to the NIH as necessary on issues that arise related to the MDCRC program. EAC members may participate in the annual meeting of the Steering Committee and be consulted as necessary.

The NIH Project Scientists representing NINDS, NIAMS, NICHD, and NHLBI will, collectively, have a single NIH vote on the MDCRC Steering Committee (see below). NIH Project Scientists will abstain from voting on any issue where they are unable to reach a consensus.

The NIH will establish one or more Data Safety Monitoring Boards to provide oversight and to advise the NIH on any clinical trials that are supported by the MDCRC awards.

Additionally, an NIH Program Official will be primarily responsible for program oversight. The Program Official assigned to each MDCRC will exercise the normal stewardship responsibilities of an NIH Program Official, including assessment of the progress of the projects toward the accomplishment of specified objectives. NIH Program Officials also retain the option of recommending termination of studies if technical performance falls below acceptable standards, or when specific lines of research cannot be effectively pursued in a timely manner. This Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Overall coordination of the MDCRC Program will be done by a Steering Committee. The MDCRC Steering Committee will make strategic decisions with regard to goals and research implementation, including the establishment and development of collaborations.

The Steering Committee will consist of the Center Directors and Co-Directors of each MDCRC, NIH Project Scientists and a public member. The Steering Committee will be chaired and co-chaired by MDCRC Center Directors, who are elected by vote of the Steering Committee for staggered two-year terms. The Chair and Co-Chair will be responsible for conduct of regular conference calls.  The Steering Committee will hold a face-to-face meeting at least annually.  Each MDCRC and the public member will have one vote on the Steering Committee and the NIH Project Scientists, collectively, will have a single NIH vote.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Glen H. Nuckolls, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: (301) 594-4974
Email: nuckollg@mail.nih.gov

Ljubisa Vitkovic, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 402-1822
Email: vitkovil@mail.nih.gov

John D. Porter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-5739
Email: porterjo@ninds.nih.gov 

Jonathan R. Kaltman, M.D.
National Heart, Lung, Blood Institute (NHLBI)
Telephone: (301) 435-0510
Email: kaltmanj@nhlbi.nih.gov

Peer Review Contact(s)

W. Ernest Lyons, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

Sheila Simmons
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: (301) 594-9812
Email: simmonsS@mail.nih.gov

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 435-6975
Email: clarkb1@mail.nih.gov

Tijuanna DeCoster, MPA
National Institutes of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9231
Email: decostert@ninds.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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